Job Description Summary
Join the largest biotechnology company in Canada and utilize your expertise to disseminate the evolving landscape of regulatory requirements. As a Senior Regulatory Affairs Specialist, your knowledge and guidance will ensure that STEMCELL's products continue supporting various stages of life science research. You are quality-driven, with an immense attention to detail to ensure every document and box is checked appropriately before submissions to drive our global reach.Job Description Duties and Responsibilities
Knowledge and Qualifications
- Identifies, interprets and applies global regulations applicable to STEMCELL's products, building/improving new processes, policies and practices to establish regulatory compliance
- Continuously grow regulatory knowledge of domestic and international regulations, guidelines, and standards while applying appropriate implementation strategies
- Regulatory representative on project teams tasked with assessing regulatory requirements, and in conjunction with the Senior Manager, developing and executing regulatory plans to guide corporate initiatives
- Cross functional collaboration, communication and influencing is a key part of the role
- Bachelor's degree in a life science-related field with a minimum of 3 years of industry regulatory experience
- Regulatory certifications would be an asset
- Knowledge of GMP and CMC requirements for biological drugs and related regulations from major regulatory jurisdictions
- Experience writing sections of regulatory submissions for biological drugs, such as Module 3
- Understanding of In Vitro Diagnostics and Drug/Device Combination Products would be an asset
This role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as "Scientists Helping Scientists" - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada's Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
NOTE: STEMCELL's vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including with boosters) against COVID-19, as currently recommended or required by local health authorities and public health orders.
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